Congratulations to the Genentech, a member of the Roche Group, team for winning a coveted 2016 Facility of the Year Award (FOYA) in the Process Innovation category for the Cell Culture Biologics Drug Substance Plant 2 (CCP-2) Manufacturing Facility and Return to Service (RTS) project.
Developed by the International Society of Pharmaceutical Engineering (ISPE), FOYAs recognize the best pharmaceutical science and manufacturing industry projects in the world. The FOYA program seeks to showcase accomplishments in facility design, construction, and operation while sharing new technologies or advanced applications of existing technology. The FOYA judging team is made up of senior industry leaders with global experience across all sectors of the pharmaceutical and biotechnology manufacturing industry.
This year’s winning Process Innovation project focused on an upgrade to the original CCP-2 facility that was put into an “idle” status in 2010 and a fast-track Return to Service project that was driven by product demand levels that had tripled in recent years.
At 450,000 sq. ft., the CCP-2 expansion to Genentech’s Vacaville, CA facility makes it one of the largest biotechnology fermentation facilities of its kind in the world. The CCP-2 facility includes manufacturing and support space, which houses some of the largest scale cell culture drug substance production equipment in the industry, including 8 x 25 KL production reactors.
This project took an innovative approach to process and equipment design to improve the facility’s reliability and efficiency. Examples include: highly automated CIP systems, buffer concentrates, buffer bags, and in-line concentrates, as well as a centralized resin slurry and delivery system.
Process innovations include:
• High titer yields at the largest bioreactor scale used in the industry,
• The conversion of downstream processing, and
• An all-fluid handling system to support the recovery of this higher titer output compared to the original installation’s lower titer design criteria.
Upgrading the existing CCP-2 facility to support new process technology instead of constructing a new building saved the owner $50 million. The project team also finished two months ahead of an aggressive 15 month schedule, making this truly a project of perseverance and a testament to the terrific amount of drive, innovation, and creativity from everyone who worked on the project.
Fun Fact: DPR Construction was the builder for original CCP-2 Manufacturing Facility and Return to Service projects. In addition, DPR also built the Genentech Oceanside Production Operations facility, which won the ISPE’s 2007 FOYA in the Project Execution category and the overall 2007 Facility of the Year award.